asked Her Majesty's Government:
Why, if the European Union rules against vaccinating cattle for tuberculosis apply in practice only to the United Kingdom and the Republic of Ireland, they are not intending to apply to change those rules until there is an effective vaccine available.
EU legislation currently prohibits the use of bovine tuberculosis vaccines, as the use of injectable BCG vaccine for bovine tuberculosis in cattle interferes with the current tuberculin skin test. Changing such legislation requires successful negotiations with the Commission in Brussels and other member states.
The Veterinary Medicines Directorate (VMD), the UK's national regulatory body, will be the licensing authority for the vaccine. A licence will be granted only once VMD has gathered specific information on the safety, efficacy and quality of the vaccine and is satisfied that it meets the necessary criteria. By granting a licence, it also indicates that the vaccine complies with relevant EU regulations for veterinary medicines. It will also consider the role of the current tuberculin diagnostic test alongside the vaccine. This will facilitate the formal negotiation for inclusion of cattle vaccine use in EU legislation.
Prior to the licensed vaccine being available, the Government will engage in discussions with the Commission and other member states to facilitate the formal negotiation process.